Device Dossier
Knee wedge
Device Dossier for Knee wedge (Knee wedge, Class IIb, sponsor Stryker). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Knee wedge
- Sponsor: Stryker
Intended purpose
An augment component of the Rotating Hinge Knee System used to fill bone defect. The Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s): - There is a destruction of the joint surfaces, with or without significant bone deformity. - The cruciate and/or collateral ligaments do not stabilize the knee joint. - The ligaments are inadequate and/or the musculature is weak. And/or - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.